Cytiva, KM5V002P2G, Pall™ Emflon™ II membrane in Mini Kleenpak™ 20 capsules, 0.2 µm sterilizing grade, 20 cm² EFA, suitable for gamma irradiation, box of 3

Mini Kleenpak™ 20 capsules with Emflon™ II membrane, part of our Pall filtration portfolio, deliver gamma-compatible sterilizing grade air filtration for use on small-scale process gas and vent applications.
Mini Kleenpak 20 capsules are suited to both the filtration of low volumes of fluids (50 mL to 2 L) in the laboratory for filterability purposes, or in a GMP production environment where a certified filter product is essential and a single-use alternative to the cleaning of 47 mm disc holders is desired.
For single-use installations, from upstream to final formulation and fill, Emflon II membrane air capsule filter is the go-to gas filter for safeguarding cell cultures and drug products from adventitious bacterial and viral contamination.
Key features /h2>
Highly retentive Emflon II membrane for sterility assurance High flow rates associated with low differential pressure enable the use of small filters leading to a reduction of installation and operating costs Gamma-irradiatable or autoclavable for maximum convenience Integrity testable using the bubble point test
High quality standards
Validated in liquids with Brevundimonas diminuta (ATCC 19146) at a challenge level of 107 organisms/cm2 of filter area 100% integrity tested during manufacturing Filters supplied with a pharmaceutical certificate of test Comprehensive validation guide available Manufactured under a Quality Management System certified to ISO 9001:2015
Biological Tests
Meets USP biological reactivity tests in vivo, in accordance with USP class VI plastics at 121°C
Effluent Quality Tests*
Meets cleanliness per USP particulates in injectables Non-fiber-releasing per 21CFR 211.72 and 21CFR 210.3(b)(6) Non-pyrogenic per USP bacterial endotoxins (< 0.25 EU/mL)
* Per lot samples on rinse-up flush aliquots